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Multidisciplinary Studies of HIV/AIDS and Aging (R01 Clinical Trial Optional)

PAR
Monday, November 23, 2020
Clinical Trials Research
Monday, January 8, 2024
R01
PAR-21-068

Funding Opportunity Purpose

This FOA encourages applications at the intersection of HIV and aging by addressing two overarching objectives: 1) to improve understanding of biological, clinical, and socio-behavioral aspects of aging through the lens of HIV infection and its treatment; and 2) to improve approaches for testing, prevention, and treatment of HIV infection, and management of HIV-related comorbidities, co-infections, and complications in different populations and cultural settings by applying our current understanding of aging science. Applications appropriate to this FOA should be consistent with the scientific priorities outlined by the NIH Office of AIDS Research (OAR) as described in NOT-OD-20-018.

Small Vessel VCID Biomarker Validation Consortium Sites (U01)(Clinical Trials Not Allowed)

RFA
Monday, November 23, 2020
Wednesday, March 10, 2021
U01
RFA-NS-21-005

Funding Opportunity Purpose

T?o invite applications to an open competition to be one of up to 7 supported sites in the next phase of the NINDS small vessel vascular contributions to cognitive impairment and dementia (VCID) biomarkers consortium. The original consortium, established under RFA-NS-16-019 and RFA-NS-16-020, pursued initial stages of multi-site validation of 11 candidate imaging-based and fluid-based biomarkers. The primary objective of the next 5 years is to carry out comprehensive multi-site clinical validation of up to six of these 11 biomarkers to be selected by the NINDS in a process separate from this FOA. The focus will be validation in longitudinal studies of diverse all-comers populations that are typical in clinical settings in the United States. The network of sites will provide scientific expertise and experimental infrastructure to pursue these goals synergistically including with the Coordinating Center (RFA-NS-21-004). At the conclusion of clinical validation each biomarker will have a designated category and context of use as defined by the FDA and a finalized public protocol that describes all details needed to utilize the biomarker. The sites will drive the consortium scientifically and contribute administratively to comprehensive rigorous clinical validation of biomarkers for future clinical trials, including in large phase III trials, and for generating scientific breakthroughs in our understanding and treatment of VCID.

Small Vessel VCID Biomarkers Validation Consortium Coordinating Center (U24 Clinical Trial Not Allowed)

RFA
Monday, November 23, 2020
Wednesday, March 10, 2021
U24
RFA-NS-21-004

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to have an open competition to support a Coordinating Center for the next phase of the NINDS small vessel vascular contributions to cognitive impairment and dementia (VCID) biomarkers consortium. The original consortium was established under RFA-NS-16-019 and RFA-NS-16-020. The goal of the next phase, under RFA-NS-20-004 (Coordinating Center) and RFA-NS-20-005 (sites), is to complete clinical validation of biomarkers initially developed during the first 5-year funding cycle of this program. The Coordinating Center will consist of: (i) an Administrative Core responsible for organizing, coordinating and administratively driving Consortium activities; and (ii) a Data Core that will coordinate, receive, collect, and share data, including de-identified clinical data. The Coordinating Center will drive the consortium administratively and contribute scientifically to validation of biomarkers with specified context of use for future clinical trials, including in large phase III trials, with general and diverse populations, and for generating scientific breakthroughs in our understanding and treatment of VCID.

Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)

PAR
Thursday, November 19, 2020
Friday, September 8, 2023
U44
PAR-21-057

Funding Opportunity Purpose

The purpose of this Program Announcement (PAR) is to enable analytical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of analytical methods for biomarker measurements, including evaluation of the detection method, its performance characteristics, and the optimal conditions that will generate reproducibility and accuracy consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed, and 3) the research and/or clinical need and potential context of use has been identified.

Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders(U01 Clinical Trial Optional)

PAR
Thursday, November 19, 2020
Friday, September 8, 2023
U01
PAR-21-056

Funding Opportunity Purpose

The purpose of this Program Announcement (PAR) is to enable analytical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of analytical methods for biomarker measurements, including evaluation of the detection method, its performance characteristics, and the optimal conditions that will generate reproducibility and accuracy consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed, and 3) the research and/or clinical need and potential context of use has been identified.

Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)

PAR
Thursday, November 19, 2020
Friday, September 8, 2023
U01
PAR-21-058

Funding Opportunity Purpose

The purpose of this Program Announcement (PAR) is to enable clinical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of biomarker measurements within the clinical population of interest to establish the positive and negative predictive values of the candidate biomarker consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed and analytically validated, and 3) the research and/or clinical need and potential context of use has been identified.

Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)

PAR
Thursday, November 19, 2020
Friday, September 8, 2023
U44
PAR-21-059

Funding Opportunity Purpose

The purpose of this Program Announcement (PAR) is to enable clinical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of biomarker measurements within the clinical population of interest to establish the positive and negative predictive values of the candidate biomarker consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed and analytically validated, and 3) the research and/or clinical need and potential context of use has been identified.

Notice of Special Interest: Administrative Supplement for Research and Capacity Building Efforts Related to Bioethical Issues (Admin Supp Clinical Trial Optional)

Notice of Special Interest
Tuesday, November 17, 2020
Friday, March 5, 2021
333
NOT-OD-21-020

Funding Opportunity Purpose

The NIH Office of Science Policy (OSP) within the Office of the Director (OD) announces the availability of administrative supplements to support 1) research on bioethical issues to develop or support the development of an evidence base that may inform future policy directions, and/or 2) certain efforts to develop or augment bioethics research capacity. Applicants may propose to supplement parent awards focused on bioethics or to add a component related to bioethics to a parent award in which bioethics was not the focus. Note that applications must be within the general scope of the parent award.

Research Supplements to Promote Diversity in Health-Related Research (Admin Supp Clinical Trial Not Allowed)

PA
Monday, November 16, 2020
Monday, May 8, 2023
333
PA-21-071

Funding Opportunity Purpose

The National Institutes of Health (NIH) and the Centers for Disease Control and Prevention hereby notify Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) holding specific types of research grants (activity codes listed above) that funds are available for administrative supplements to enhance the diversity of the research workforce by recruiting and supporting students, postdoctorates, and eligible investigators from diverse backgrounds, including those from groups that have been shown to be underrepresented in health-related research. This supplement opportunity is also available to PD(s)/PI(s) of research grants who are or become disabled and need additional support to accommodate their disability in order to continue to work on the research project. Administrative supplements must support work within the scope of the original project. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.

Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Basic Experimental Studies with Humans Required)

PAR
Monday, November 9, 2020
Friday, December 29, 2023
R01
PAR-21-039

Funding Opportunity Purpose

The Stephen I. Katz Early Stage Investigator Research Project Grant supports an innovative project that represents a change in research direction for an early stage investigator (ESI) and for which no preliminary data exist. Applications submitted to this Funding Opportunity Announcement (FOA) may not include preliminary data. The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions. This Funding Opportunity Announcement is for basic science experimental studies involving humans, referred to in NOT-OD-18-212 as prospective basic science studies involving human participants. These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. Types of studies that should submit under this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind. Studies conducted with specific applications toward processes or products in mind should submit under the appropriate Clinical Trial Required or Clinical Trial Not Allowed" FOA

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